Dehydrated Human Amnion Membrane for Diabetic Foot Ulcers
This study is looking at a new way to help non-healing diabetic foot ulcers (sores on the foot that don't heal well). It compares two treatments: standard of care (cleaning, debridement, moisture balance, and offloading) alone, versus standard of care combined with a product called Axolotl DualGraft (dehydrated human amnion membrane). You could be eligible if you are at least 18 years old, have type 1 or 2 diabetes, and a foot ulcer between 1.0 and 5.0 cm² in size after cleaning. The main goal is to see how well each treatment helps the ulcers close within 12 weeks. The study plans to enroll 100 participants.
- Study design
- This is a multi-center randomized controlled clinical trial. It plans to enroll 100 participants.
- What's involved
- Participants will receive weekly treatment with either standard of care alone or Axolotl DualGraft plus standard of care. Treatment will continue until the ulcer closes or for a maximum of 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures how well ulcers close within 1 to 12 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06550596
Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers
Recruiting
NAAges 18+InterventionalTreatmentAxolotl Biologix
~100 participants
Updated 2025-01-30 on ClinicalTrials.gov
What's tested:Standard of CareAxolotl DualGraft + SOC
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of dhAM + SOC vs SOC
Measured over 1-12 Weeks
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Subjects must be at least 18 years of age or older.
Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 5.0 cm2 measured post debridement.
The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
The target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.
The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
The subject must consent to using the prescribed offloading method for the duration of the study.
The subject must agree to attend the weekly study visits required by the protocol.
The subject must be willing and able to participate in the informed consent process.
Exclusion
A subject known to have a life expectancy of \< 6 months is excluded.
The subject is excluded if the target ulcer is not secondary to diabetes.
If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.
If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.
A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.
A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
The subject is excluded if the surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).
The subject is excluded if the surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1/randomization visit, during which time the subject received SOC.
A subject is excluded if they are malnourished: a score of less than 17 on the Mini Nutritional Assessment (MNA).
A Subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.
Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
A potential subject with end stage renal disease requiring dialysis is excluded.
A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.
A Subject treated with hyperbaric oxygen therapy or a Cellular Acellular, or Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit is excluded.
What this trial measures
- Efficacy of dhAM + SOC vs SOC1-12 Weeks
To determine the efficacy of dhAM plus SOC versus SOC alone in achieving complete closure of nonhealing diabetic foot ulcers over 12 weeks.